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GB/T 16294-2010 (GBT16294-2010)

GB/T 16294-2010_English: PDF (GBT 16294-2010, GBT16294-2010)
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Standard ID GB/T 16294-2010 (GB/T16294-2010)
Description (Translated English) Test method for settling microbe in clean room (zone) of the pharmaceutical industry
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 13.040.30
Word Count Estimation 11,190
Date of Issue 2010-09-02
Date of Implementation 2011-02-01
Older Standard (superseded by this standard) GB/T 16294-1996
Quoted Standard GB/T 16292-2010
Drafting Organization Shanghai Food and Drug packaging materials testing
Administrative Organization State Food and Drug Administration
Regulation (derived from) National Standard Announcement 2010 No.4 (Total No.159)
Proposing organization State Food and Drug Administration
Issuing agency(ies) Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China; Standardization Administration of China
Summary This standard specifies the pharmaceutical industry cleanrooms and clean zones settlement bacteria test conditions, test methods. This standard applies to the pharmaceutical industry clean room and clean area, verify sterile room or local air purification area (including clean bench) settlement bacteria test and the environment.

Standards related to: GB/T 16294-2010

GB/T 16294-2010
ICS 13.040.30
C 30
Replacing GB/T 16294-1996
Test method for settling microbe in clean
room (zone) of the pharmaceutical industry
Issued by. China Food and Drug Administration
Table of Contents
Foreword . 3
1 Scope .. 4
2 Normative references . 4
3 Terms and definitions . 4
4 Test method . 5
5 Test rules . 7
Annex A (normative) Clean room (zone) sampling point layout . 12
Annex B (normative) Sterilization and preparation of culture medium .. 14
Annex C (informative) Technical requirements for settling microbe in clean room
(zone) . 16
This Standard refers to ISO 14698-1 “Cleanrooms and associated controlled
environments - Biocontamination control - Part 1. General principles and
methods”, ISO/TS 11133-1.2000 (English version) “Microbiology of food and
animal feeding stuffs - Guidelines on preparation and production of culture
media - Part 1. General guidelines on quality assurance for the preparation of
culture media in the laboratory”.
This Standard replaces GB/T 16294-1996 “Test method for settling microbe in
clean room (area) of the pharmaceutical industry”.
The main differences between this Standard and GB/T 16294-1996 are.
- ADD the method for determining the minimum number of sampling points;
- MODIFY the original standard to “4.10.2 [Translator’s note. this
should be 4.4.5 in this Standard] The petri dish prepared by soybean casein
agar medium (TSA) are sampled and cultured in the incubator at 30 °C to
35 °C for no less than 2 d. The petri dish prepared by sabouraud medium
(SDA) are sampled and cultured in the incubator at 20 °C ~ 25 °C for no
less than 5 d.”;
- ADD the content of 5.8 “Daily monitoring”, ADD the establishment of
correcting limits and warning limits for the control of microbial concentration
in the air of clean room (zone) and the content of how to determine the
sampling frequency in this Standard.
Annex A and Annex B of this Standard are normative annexes.
Annex C of this Standard is an informative annex.
This Standard was proposed and shall be under the jurisdiction of China Food
and Drug Administration.
Drafting organizations of this Standard. Shanghai Food and Drug Packaging
Material Control Center, China Food and Drug Testing Institute Medical Device
Testing Center.
Main drafters of this Standard. Lu Weiyi, Xu Minfeng, Feng Xiaoming, Wang
The historical edition of the standard replaced by this Standard is. GB/T 16294-
Test method for settling microbe in clean
room (zone) of the pharmaceutical industry
1 Scope
This Standard specifies the test conditions and test method for setting microbe
in clean room and clean zone of the pharmaceutical industry.
This Standard is applicable to the test of setting microbe in clean room and
clean zone of the pharmaceutical industry, and in sterile room or local air
purification area (including the clean bench), and the verification of the
2 Normative references
The following documents contain the provisions which, through reference in this
Standard, become the provisions of this Standard. For dated references, their
subsequent amendments (excluding corrigendum) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest versions of these
documents are applicable. For undated reference documents, the latest
versions apply to this Standard.
GB/T 16292-2010 Test method for airborne particles in clean room(zone) of
the pharmaceutical industry
3 Terms and definitions
For the purpose of this Standard, the following terms and definitions apply.
settling microbe
Visible number of colonies that are colonized using living microbial particles in
the air collected by the method mentioned in this Standard, in special culture
medium, under suitable growth conditions.
settling microbe plate count
Number of setting microbe in the air that are collected in each plate petri dish
in the specified period of time, expressed in cells/dish.
4 Test method
4.1 Method summary
This test method adopts the sedimentation method, that is, collect biological
particles in the air on the culture medium plate through natural sedimentation
principle, after some time, let it grow to visible colonies under appropriate
conditions and count, determine the number of living microorganisms in a clean
environment by counting the number of colonies in the plate petri dish, so as to
assess the cleanliness of the clean room (zone).
4.2 Personnel responsibility and training
The test personnel of the clean room (zone) shall be trained in this specialty
and obtain relevant qualifications before they can perform their duties in the
clean room (zone) test, which includes hygienic knowledge and basic
knowledge of the microorganisms involved.
The test personnel of the clean room (zone) shall select the wear that suits the
air cleanliness grade requirements of the production operation, and the outer
clothes cannot be brought into the area of 100 000 grade or more.
4.3 Instruments
The instrument shall include.
a) petri dish;
b) culture medium (see Annex B of this Standard);
c) constant temperature incubator;
d) high pressure steam sterilizer.
4.3.1 Petri dish
It generally uses φ90 mm × 15 mm petri dishes.
4.3.2 Culture medium
Soybean casein agar medium (TSA) or sabouraud medium (SDA) or user-
approved and validated medium. The preparation method is shown in Annex B. For unidirectional-flow clean rooms (zones) or air supply ports, the
sampling port of the sampler shall face the airflow direction; for non-
unidirectional-flow clean rooms (zones), the sampling port shall be upward. When arranging the sampling points, it shall at least avoid the return air
outlets with relatively concentrated dust particles as far as possible. When sampling, the testing personnel shall stand on the downwind side
of the sampling port and move as little as possible. It shall take all measures to prevent contamination during the sampling
process and other possible contamination of the sample. When the petri dish is used for testing, in order to avoid the influence of
the process of transporting or moving the petri dish, it should carry out a control
test at the same time. TAKE a control dish each time or at each area, OPERATE
in the same way as the sampling dish without exposing the sampling, and then
PLACE it in the incubator along with the sampled petri dish (TSA or SDA). The
result shall be there is no colonies.
5.5 Records
The test report shall contain the following.
a) name and address of the tester, test date;
b) test basis;
c) plane position of the clean room (zone) to be tested (mark the plane
position of the adjacent area if necessary);
d) description of the test instrument and the test method. including test
environmental conditions, number of sampling points and layout diagram,
number of tests, or possible changes in the test method, test instrument
certification certificates, etc.; if it is a dynamic state test, it shall record the
number and location of on-site operators and the number and location of
on-site instruments.
e) test result; including all statistical calculation data.
5.6 Result calculation
5.6.1 Count the number of colonies in each petri dish.
5.6.2 For the calculation of the average colony count of setting microbe at each
test point, see equation (1).